1) recommend best (preclinical) practices for efficiently evaluating and developing agents in the...

Cancer Clinical Trials Aimed at Decreasing

Toxicity

1) recommend best (preclinical) practices for efficiently evaluating and developing agents in the CMCR pipeline for possible applications in cancer patients

2) iron out how to efficiently move the most promising agents into appropriate clinical trials

3) develop a summary "position paper" to be published

• Minimize DELAY and CONFUSION

• Quality of life (mid 1980’s)

• Fatigue (2000)

• Curcumin  (2006)

QOL and cancer in title 1980 =  2 = .05% of articles with cancer in title (cancer alone = 3966)QOL and cancer 2008 =  355 = 1.2% of articles with cancer in title (cancer alone = 29940)

• June 30, 2006  IND submitted• August 4, 2006 IND approved• August 31, 2006 “complete clinical

hold”

• July 25, 2007 “proceed”• July 26, 2007 “hold”• August 16, 2007 “approved”

Involved :• 9 FDA staff• 4 FDA divisions• 1 FDA Ombudsman• 1FDA Chief• 1 US Congresswoman• 1 US Senator• 8 University of Rochester people

And 57 separate contacts over the 412 days

What is a CCOP Research Base?

An NCI-designated Cancer Center or Cooperative Group

Funded by a Peer- Reviewed Cooperative Agreement

Develop and Conduct Cancer Prevention and Control Clinical Trials

Supports Development of Cancer Prevention Science

CCOP Research Bases: Cooperative Groups

▪ Children’s Oncology Group▪ Cancer and Leukemia Group B▪ Eastern Cooperative Oncology Group▪ North Central Cancer Treatment Group▪ Radiation Therapy Oncology Group▪ Southwest Oncology Group▪ National Surgical Adjuvant Breast &

Bowel Project▪ Gynecologic Oncology Group

CCOP Research Bases: Cancer Centers

H. Lee Moffitt Cancer Center M.D. Anderson Cancer Center University of Rochester Cancer Center

Wake Forest University Cancer Center

Central Illinois CCOP Gulf Coast MBCCOP North Shore University Hospital CCOPColumbia River CCOP Hawaii MBCCOP Northwest CCOP

Columbus CCOP Hematology-Oncology of CNY CCOPSoutheast Cancer Control Consortium

Dayton Clinical Oncology Program Kalamazoo CCOPUniversity of Illinois at Chicago MBCCOP

Evanston CCOP Kansas City CCOP Upstate Carolina CCOP

Grand Rapids CCOPMarshfield Clinic Research Foundation CCOP

Virginia Mason Research Center CCOP

Greenville CCOP Metro-Minnesota CCOP Wichita CCOPNevada Cancer Research Foundation CCOP

CCOPs

URCC

UNIVERSITY OF ROCHESTER CANCER CENTERCOMMUNITY CLINICAL ONCOLOGY RESEARCH BASEMAP OF AFFILIATES (2009)

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2

4

6

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10

2000 2001 2002 2003 2004 2005 2006 2007 2008Cancer Control Accruals(CCOPs and MBCCOPs)

Tho

usan

ds

• What is appropriate FDA review expertise for this research? 

• Where is it found administratively? 

• How can mutually beneficial collaborative  relationships be promoted?

• Is there a way to have this all be more timely?

Gary Morrow, PhD, MS URCC CCOP Research Base 20

CCOPs & [MB-CCOPs]

Accrual to Protocols

Data Management

Quality Control

Research Bases

(Groups/Centers)

Develop Protocols

Data Management and Analysis

Quality Assurance

Members and Affiliates

Accrual to Prevention and Control Protocols

March 2007

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